Trial Outcomes & Findings for Anchorsure Versus Capio for Sacrospinous Ligament Fixation (NCT NCT03565640)

Results Overview

This will be assessed using the numeric rating scale (NRS). The score is 0-10, with higher scores denoting a greater degree of pain.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

48 participants

Primary outcome timeframe

postoperative 12 month

Results posted on

2023-02-16

Participant Flow

Participant milestones

Participant milestones
Measure	Capio Slim Device Participants will be randomized to the sacrospinous ligament fixation with use of Capio Slim Device Capio Slim Device: Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Capio Slim Device.	Anchorsure Device Participants will be randomized to the sacrospinous ligament fixation with use of Anchorsure Device Anchorsure Device: Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Anchorsure Device.
Overall Study STARTED	23	24
Overall Study COMPLETED	22	21
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anchorsure Versus Capio for Sacrospinous Ligament Fixation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Capio Slim Device n=22 Participants Participants will be randomized to the sacrospinous ligament fixation with use of Capio Slim Device Capio Slim Device: Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Capio Slim Device.	Anchorsure Device n=21 Participants Participants will be randomized to the sacrospinous ligament fixation with use of Anchorsure Device Anchorsure Device: Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Anchorsure Device.	Total n=43 Participants Total of all reporting groups
Age, Continuous	70.1 years STANDARD_DEVIATION 10.7 • n=5 Participants	68.7 years STANDARD_DEVIATION 8.8 • n=7 Participants	69.4 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Body Mass Index	30.1 kg/m^2 STANDARD_DEVIATION 6.4 • n=5 Participants	29.9 kg/m^2 STANDARD_DEVIATION 6.6 • n=7 Participants	30.0 kg/m^2 STANDARD_DEVIATION 6.4 • n=5 Participants
POP-Q Stage Score	2.7 Units on a scale STANDARD_DEVIATION 0.6 • n=5 Participants	2.8 Units on a scale STANDARD_DEVIATION 0.8 • n=7 Participants	2.7 Units on a scale STANDARD_DEVIATION 0.7 • n=5 Participants

PRIMARY outcome

Timeframe: postoperative 12 month

This will be assessed using the numeric rating scale (NRS). The score is 0-10, with higher scores denoting a greater degree of pain.

Outcome measures

Outcome measures
Measure	Capio Slim Device n=22 Participants Participants will be randomized to the sacrospinous ligament fixation with use of Capio Slim Device Capio Slim Device: Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Capio Slim Device.	Anchorsure Device n=21 Participants Participants will be randomized to the sacrospinous ligament fixation with use of Anchorsure Device Anchorsure Device: Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Anchorsure Device.
Change in Buttock and Posterior Thigh Pain Sacrospinous ligament fixation site Pain compared to preop	-0.5 score on a scale Standard Deviation 1.6	-0.2 score on a scale Standard Deviation 0.9
Change in Buttock and Posterior Thigh Pain Worst pain compared to preop	-1.8 score on a scale Standard Deviation 3.1	-1.5 score on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: at 12 MONTHS

The stage is assigned as follows: 0 if there is no prolapse at all, 1 if there is prolapse but the leading point is not within 1cm of the hymen, 2 if the leading point is within 1 cm of the hymen (from 1cm within the hymen to 1cm beyond the hymen), 3 if the leading point is more than 1cm from the hymen but less than 2cm from being completely prolapsed, and 4 if the leading point is within 2cm of being complete prolapsed. Therefore higher POP-Q stages correlate to a worse degree of prolapse than lower POP-Q stages.

Outcome measures

Outcome measures
Measure	Capio Slim Device n=18 Participants Participants will be randomized to the sacrospinous ligament fixation with use of Capio Slim Device Capio Slim Device: Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Capio Slim Device.	Anchorsure Device n=19 Participants Participants will be randomized to the sacrospinous ligament fixation with use of Anchorsure Device Anchorsure Device: Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Anchorsure Device.
POP-Q Stage Score	0.8 Units on a scale Standard Deviation 0.9	0.9 Units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: These are the two study groups where patients were randomized to either have the Anchorsure or Capio Slim device used for their sacrospinous ligament fixation.

Symptomatic success was assessed by the pelvic floor disability index (PFDI-20) questionnaire. The PFDI-20 has 20 items within 3 sub-scales of symptoms (total of 20 items). Each item produces a response of 0 to 4, the average response in each sub-scale is multiplied by 25 to obtain the sub-scale score (range 0 to 100). The total score is the sum of the three sub-scale scores with a range of 0-300. Higher value for a time-point score indicates a greater degree of symptom bother. The difference in scores across the study time-points was calculated by subtracting the total score at baseline from the score at 12 months post-operation. A negative value for the difference in scores from baseline to 12 months indicates symptom improvement, where the more negative the difference in score is the greater the improvement in symptoms.

Outcome measures

Outcome measures
Measure	Capio Slim Device n=22 Participants Participants will be randomized to the sacrospinous ligament fixation with use of Capio Slim Device Capio Slim Device: Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Capio Slim Device.	Anchorsure Device n=21 Participants Participants will be randomized to the sacrospinous ligament fixation with use of Anchorsure Device Anchorsure Device: Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Anchorsure Device.
Change in Pelvic Flore Disability Index - 20 (PFDI-20) Scores From Baseline to 12 Months	-66.3 score on a scale Standard Deviation 64.4	-71.0 score on a scale Standard Deviation 45.5

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: These are the two study groups where patients were randomized to either have the Anchorsure or Capio Slim device used for their sacrospinous ligament fixation.

Symptomatic success will be assessed by the Pelvic Floor Impact Questionnaire - 7 (PFIQ-7). The PFIQ-7 has 7 items for each of 3 sub-scales (total of 21 items). Each item produces a response of 0 to 3, the average response in each sub-scale is multiplied by 100/3 to obtain the total scale score (range 0 to 100). The total score is the sum of the three sub-scale scores with a range of 0-300. Higher value for a time-point score indicates a greater degree of symptom bother. The difference in scores across the study time-points was calculated by subtracting the total score at baseline from the score at 12 months post-operation. A negative value for the difference in scores from baseline to 12 months indicates symptom improvement, where the more negative the difference in score is the greater the improvement in symptoms.

Outcome measures

Outcome measures
Measure	Capio Slim Device n=22 Participants Participants will be randomized to the sacrospinous ligament fixation with use of Capio Slim Device Capio Slim Device: Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Capio Slim Device.	Anchorsure Device n=21 Participants Participants will be randomized to the sacrospinous ligament fixation with use of Anchorsure Device Anchorsure Device: Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Anchorsure Device.
Change in Symptomatic Success - PFIQ-7 Scores	-26.4 score on a scale Standard Deviation 65.7	-40.6 score on a scale Standard Deviation 62.4

Adverse Events

Capio Slim Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Anchorsure Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sachin Vyas

Atrium Wake Forest Baptist Health

Phone: 7865564412

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place